Country Study Start Up Team Leader

The Position

In Roche’s Global Clinical Operations (PDG) team, the Country Study Start-up Team Leader (cSTL) takes on a dual-impact role that is vital to the mission. You will be the driving force behind clinical trial submissions while simultaneously serving as a People Leader for approximately 30% of your time, guiding a dedicated team to success in country delivery operations.

In this pivotal role, you will balance strategic oversight of study start-up with hands-on leadership in regulatory submissions and people management. Your work ensures that innovative medicines are delivered to patients faster and more efficiently by streamlining the bridge between clinical design and site activation.

In this role, you will:

• Lead the country strategy for study start-up, driving efficiency and innovation to ensure timely site activation.
• Drive clinical trial submissions and regulatory coordination, managing complex submission packages and responding to Health Authority queries.
• Serve as a People Leader for approximately 30% of your time, providing coaching, support, and professional development to your direct reports.
• Architect and oversee the management of Informed Consent Forms (ICF) and clinical site documentation to ensure global compliance.
• Champion process innovation by identifying opportunities for automation to improve trial initiation timelines.
• Collaborate with global stakeholders, including CROs and Health Authorities, to harmonise systems and influence the local start-up environment.
• Manage clinical site budgets and contracts, ensuring financial and legal alignment through expert negotiation.

Who you are

You are a proactive, visionary leader who combines deep technical expertise in clinical submissions with a genuine passion for developing others. You thrive in complex, matrixed environments and possess the analytical prowess to turn data into strategic improvements.

To be successful in this role, you bring:

• Proven experience in clinical trial start-up and regulatory submissions, with deep knowledge of ICH-GCP and EU CTR.
• A track record in coaching, mentoring, and leading high-performing teams to deliver significant business impact.
• A university degree (MD, PhD, MS, or BS) in life sciences; a postgraduate degree is highly desirable.
• Experience navigating complex clinical systems such as Veeva Vault, CTIS, and RIM.
• The ability to influence and partner with stakeholders, from local operational teams to global executive leadership.
• Mandatory fluency in English; fluency in Dutch is strongly preferred.

Why Roche?

Roche works to advance science so that people have more time with the people they love. In this role, you will contribute to delivering life-changing healthcare solutions and work in an environment where expertise is valued and autonomous decision-making is encouraged.

What you get from us:

• A workplace where fun and social impact come together.
• An organisation where your expertise is valued, and you can make autonomous decisions within your team.
• The chance to work with products that are fundamentally transforming oncological care.
• Abundant opportunities for personal and professional growth; Roche invests in your unique path.
• Excellent benefits including a half 13th month, performance-based bonus, lease car, 30.5 days of holiday, and participation in the stock program.